Moderna is seeking an Associate Director to drive genomic and molecular assay needs across clinical stage oncology programs. This position reports to Modernas Director of Clinical Biomarkers. The Associate Director will work collaboratively across several clinical and translational teams (internal, external CROs, partners) to ensure genomic and molecular assay development strategy, planning, execution and timely data delivery for clinical trials conducted by Moderna.
Heres What Youll Do:
Bring in depth knowledge and expertise in established and emerging technologies, such as NGS, scRNAseq, CITE-Seq, TCR sequencing, spatial transcriptome profiling, and other relevant biomarker assays to implement in Oncology clinical trials.
Have in depth technical knowledge of biomarker assays, especially NGS assay in regulated environment following US and other countries regulatory guidelines.
Oversee assay development/implementation efforts in clinical biomarker team by partnering with preclinical and clinical biomarker lab teams to understand current assay status and potential vendor or internal laboratory requirements for oncology programs.
Develop and provide operational input and recommendations into all study related documentation (including protocol, lab manual, informed consent form, and amendments) and processes, and ensure collection, delivery, and analysis of bio-samples in compliance with these documents as well as GCP/ICH as needed
Work in collaboration with clinical biomarker lab, translational and research teams to support overall biomarker assay development strategies for oncology programs and bring a deep understanding of relevant biomarker technologies to teams
Contribute to evaluation of biomarker vendors by providing technical expertise in biomarker assays
Heres What Youll Bring to the Table:
PhD (with at least 3 years pharmaceutical/biotechnology experience) or MS (with at least 8 years of pharmaceutical/biotechnology experience in an oncology science, expertise in clinical biomarker assay development in highly desirable
In depth knowledge in molecular assays, such as NGS, scRNAseq, TCR sequencing are required. Knowledge in other immunoassays, such as Immunogenicity assessment, special transcriptome analysis is desired
Experience in CRO management, biomarker assay qualification/validation, deep understanding of assay development under regulated environment (CLIA, GCP/GCLP or equivalent) is highly preferred.
Solid experience in the application of biomarkers during clinical development including experience with clinical translational research, development, validation and implementation of biomarkers in the Oncology space.
Strong communication, organization and record keeping skills are required.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+ community
- Generous paid time off, including:
Vacation, sick time and holidays
Volunteer time to participate within your community
Discretionary year-end shutdown
Paid sabbatical after 5 years; every 3 years thereafter
- Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras!
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at email@example.com. (EEO/AAP Employer)